Exergen Temporal Scanner TAT5000Recalls & reported problems
Exergen Corporation · TAT5000 Arterial Calibration · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10834098000089), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2018Incorrect, Inadequate or Imprecise Result or Readings
VITAL SIGNS TAKEN, TEMPERATURE RECORDED OF 103.1 AND MEDICATED WITH PRN ORDER. DISCOVERED LATER THAT THE THERMOMETER WAS READING INADEQUATELY ON ALL PATIENTS. CALLED BIOMED TO TAKE EQUIPMENT. WHEN TESTED WITH CALIBRATED TESTER THE THERMOMETER WAS FOUND TO BE OFF BY 1 DEGREE FAHRENHEIT. ACCURACY IS +/- .2 DEGREES FAHRENHEIT. DEVICE WILL BE RETURNED TO MANUFACTURER FOR EXCHANGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7909499 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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